Eight of Eight Patients Successfully Transitioned from Oral Tacrolimus to TFF TAC with No Sign of Acute Rejection at Reduced Systemic Exposures
Data from TFF VORI Phase 2 and EAP Program Continue to Demonstrate Antifungal Activity and a Favorable Safety and Tolerability Profile
TFF TAC Program Prioritized Based on Positive Phase 2 Data, the Potential to Address a Significant Unmet Need in Lung Transplant Medicine and Substantial Market Opportunity
Company to Hold Conference Call and Webcast Today at
“Today’s updated data provide further promising evidence in support of the continued development of both TFF TAC and TFF VORI, with the interim clinical data suggesting that each product can be delivered safely and efficaciously into the lungs,” said
TFF TAC and TFF VORI Clinical Data Updates
Today, the Company is presenting new data from the ongoing Phase 2 study of TFF TAC for the prevention of acute rejection in lung transplant, and from the Phase 2 study and the Expanded Access Program (EAP) of TFF VORI for the treatment of invasive pulmonary aspergillosis (IPA). The updated safety and efficacy data are based on the cutoff date of
TFF TAC – updated Phase 2 data
The ongoing Phase 2 trial of TFF TAC is an open-label study in lung transplant patients who require reduced tacrolimus blood levels due to kidney toxicity. Part A of the trial is a 12-week treatment period, and Part B is an optional safety extension period. Trial endpoints include safety, tolerability, kidney function, and acute allograft rejection.
In December, the Company announced initial data from the first four patients enrolled in the trial. Today, the Company is presenting data from another four patients in the trial (N=8).
Updated Efficacy
- Successful transition eight of eight patients from oral Tacrolimus to TFF TAC
- No evidence of acute rejection:
- No signs and symptoms suggestive of acute rejection
- No use of pulse corticosteroids to treat acute rejection
- No deterioration in spirometry
- No chest x-ray findings suggestive of acute rejection
- 4/4 patients who completed Part A chose to remain on TFF TAC and proceeded to Part B.
Biomarker data will be disclosed at a Late Breaking Clinical Science abstract session at 44th Annual
Updated Safety
- No mortality
- No TFF TAC discontinuation due to an AE
- Majority of TEAEs were Grade 2 or lower in severity
- Maintenance of kidney function
On
TFF VORI – updated Phase 2 and EAP data
The Phase 2 trial of TFF VORI enrolled patients with IPA and evaluated TFF VORI versus oral voriconazole in a 3:1 randomization after 13 weeks of treatment in an open label study. The trial endpoints included safety and tolerability, clinical, radiologic and mycologic responses, as well as all-cause mortality.
In
As of
Updated Efficacy
- Five of six patients achieved a clinical response with TFF VORI, which we define as improvements in signs, symptoms and/or spirometry
- Five of six patients achieved a mycologic response, meaning no evidence of fungal infection on follow up assessment
- Three of four patients, who had an abnormal chest CT at baseline and also had a follow up chest CT, achieved a radiologic response, meaning improvement in radiologic findings attributable to their fungal infection.
- No need for continued anti-fungal use after treatment with TFF VORI in all six patients.
Updated Safety
- TFF VORI continues to maintain an attractive safety profile:
- No IPA-related mortality.
- No all-cause mortality
- One TFF VORI discontinuation due to an unrelated adverse event of COVID infection that required intubation.
- Majority of treatment-related adverse events (TEAEs) were deemed unrelated to TFF VORI
- Majority of TEAEs were Grade 2 or lower in severity.
- No hepatic toxicity
- No visual disturbances.
On
Conference Call and Webcast Information
The Company will host a conference call today at
Domestic Dial-In Number: Toll-Free: 1-888-886-7786
International Dial-In Number: 1-416-764-8658
Conference ID: 24531709
Call me™: LINK (will be made active 15 minutes prior to the scheduled start time)
The call will also be broadcast live over the Web and can be accessed on TFF Pharmaceuticals’ Website, https://tffpharma.com or directly at
https://viavid.webcasts.com/starthere.jsp?ei=1658279&tp_key=8445c4138a
The conference call will also be available for replay for one month on the Company's website in the Events Calendar of the Investors section.
ABOUT TFF PHARMACEUTICALS’ THIN FILM FREEZING (TFF) TECHNOLOGY
TFF Pharmaceuticals’ proprietary Thin Film Freezing (TFF) technology allows for the transformation of both existing compounds and new chemical entities into dry powder formulations exhibiting unique characteristics and benefits. The TFF process is a particle engineering process designed to generate dry powder particles with advantageous properties for inhalation, as well as parenteral, nasal, oral, topical and ocular routes of administration. The process can be used to engineer powders for direct delivery to the site of need, circumventing challenges of systemic administration and leading to improved bioavailability, faster onset of action, and improved safety and efficacy. The ability to deliver therapies directly to the target organ, such as the lung, allows TFF powders to be administered at lower doses compared to oral drugs, reducing unwanted toxicities and side effects. Laboratory data suggests the aerodynamic properties of the powders created by TFF can deliver as much as 75% of the dose to the deep lung. TFF does not introduce heat, shear stress, or other forces that can damage more complex therapeutic components, such as fragile biologics, and instead enables the reformulation of these materials into easily stored and temperature-stable dry powders, making therapeutics and vaccines more accessible for distribution worldwide. The advantages of TFF can be used to enhance traditional delivery or combined to enable next-generation pharmaceutical products.
ABOUT
SAFE HARBOR
This press release contains forward-looking statements regarding TFF Pharmaceuticals, Inc., including the advancement of TFF TAC and TFF VORI into potentially registration-enabling studies; the expectation that the initial data readouts for TFF TAC and TFF VORI will be consistent with the further data from the ongoing Phase 2 clinical trials and related EAP; and the benefits of the Company’s TFF platform. Those forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially. Among those factors are: (i) the risk that the further data from the ongoing Phase 2 clinical trials and related EAP for TFF TAC and TFF VORI will not be favorably consistent with the initial data initial data readouts, (ii) the risk that the Company may not be able to advance to registration-enabling studies for TFF TAC and TFF VORI candidates, (iii) success in early phases of pre-clinical and clinicals trials do not ensure later clinical trials will be successful; (iv) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (v) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, (vi) the risk that the Company may not be able to obtain additional working capital with which to continue the Phase 2 clinical trials and related EAP, or advance to the initiation of registration-enabling studies, for TFF TAC and TFF VORI as and when needed and (vii) those other risks disclosed in the section “Risk Factors” included in the Company’s Quarterly Report on Form 10-Q filed with the SEC on November 14, 2023. TFF Pharmaceuticals cautions readers not to place undue reliance on any forward-looking statements. TFF Pharmaceuticals does not undertake, and specifically disclaims, any obligation to update or revise such statements to reflect new circumstances or unanticipated events as they occur, except as required by law.
Investor Relations Contact:
(212) 915-2577
cdavis@lifesciadvisors.com
Source:
2024 GlobeNewswire, Inc., source